Caregiver BurdenNCT05217004

Evaluation of Mobile Apps for Informal Caregivers of People Living With Dementia

A study testing Dementia Talk mobile application and CLEAR Dementia Care mobile application in people with Caregiver Burden and Stress, run by University of Regina at 1 site in Canada.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

The purpose of this study is to evaluate the effectiveness of two currently available apps for unpaid caregivers of people living with dementia. Read more about this study

Who is it for?: Ages 18 years and olderHealthy volunteers can take part
Conditions the study is for: Caregiver Burden, Stress, Dementia
What is being tested?: Dementia Talk mobile application and CLEAR Dementia Care mobile application
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 175 participants
Where: 1 siteCanada
Study dates: 31 Jan 2022to 5 Jul 2022
Phase: Interventional
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
Healthy volunteers accepted
Adult, Older adult

Who may be able to join

providing informal care for a person living with dementia (e.g., informal caregivers who are non-professionals; this may include immediate family members such as spouses, children, and other relatives, friends)
living with or providing primary care for the person living with dementia (i.e., the care recipient is not in a long-term care facility)
providing unpaid care
own a smartphone (i.e., an iPhone or Android and/or can access either IOS or Android platforms)

Who cannot join

using an app for caregiver stress/burden

Trial locations and contacts

1 site in 1 country.

Canada1 site

University of Regina
Regina, Saskatchewan, S4S 0A2

Other trials in Canada

About this study

Official title: Systematic Evaluation of Mobile Applications for Informal Caregivers of People Living With Dementia

The purpose of this study is to evaluate the effectiveness of two currently available apps for unpaid caregivers of people living with dementia.

Read the detailed description

Informal caregivers of people living with dementia experience stressors that are associated with adverse health outcomes. Mobile applications (i.e., apps) could potentially improve the delivery and increase access to interventions. Although apps for informal caregivers of people living with dementia are available, empirical evidence to support their effectiveness is limited. The evaluation will be conducted by recruiting informal caregivers of people living with dementia. Participants will be randomly assigned to one of the two app-using groups or a wait-list condition. In the rare event that a participant experiences issues downloading an assigned app (and before commencing the 2-week period), participants will be randomly assigned to one of the other two conditions. Participants in the app-using groups will be asked to use their app for a 2-week period, and burden, stress, overall health, and knowledge will be assessed before, after the 2-week period, and at a 3-week follow-up. Subjective app ratings and usability of apps will be collected after the 2-week period. A 3 between (group) by 3 within (time: baseline, post, follow-up) mixed model (repeated measures) multivariate analysis of variance and univariate analyses will be conducted to examine improvements on outcome measures over time. Interviews will be conducted, and textual data will be analyzed thematically to examine caregiver experiences, perceptions of caregivers in using selected apps, and preferences and needs of caregivers in the development of future apps. Findings from the proposed investigation can help guide caregivers in choosing the apps that best address their needs. Moreover, findings from the investigation can inform future developments of apps to address the needs of caregivers of people living with dementia.

Conditions: Caregiver Burden, Stress, Dementia
Being tested: Dementia Talk mobile application, CLEAR Dementia Care mobile application
Keywords: Apps, mhealth
Medical subject headings: Caregiver Burden, Dementia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Dementia Talk mobile applicationOther
The app includes features for caregivers such as medication management, behavior symptom management and monitoring, stress management tips and strategies, and task management with other care providers.
CLEAR Dementia Care mobile applicationOther
The app provides information about dementia (e.g., types and symptoms of dementia) and allows caregivers to record, monitor, and chart behaviors in the care recipient.

Study groups in NCT05217004
Study group	Role	What they receive
Dementia Talk	Experimental	Participants in this group will be asked to use the mobile app Dementia Talk over a 2-week period. Receives: Other: Dementia Talk mobile application
CLEAR Dementia Care	Experimental	Participants in this group will be asked to use the mobile app CLEAR Dementia Care over a 2-week period. Receives: Other: CLEAR Dementia Care mobile application
Waitlist Control Group	No intervention	Participants in this group will not use any of the apps.

What is being measured

The primary outcome is the main question the study is designed to answer.

Change from baseline in the Zarit Caregiver Burden Interview (ZBI) total scores at 2 weeks
Caregiver burden will be assessed using the ZBI. The ZBI is a 22-item self-report questionnaire designed to measure the extent of the burden experienced by the caregivers in various dimensions (e.g., health, psychological well-being, finances, social) of their lives as a result of caregiving. Each item is rated on a Likert scale ranging from 0 (Never) to 4 (Almost always) and indicates how often the caregiver has experienced the described situation. A total score ranging from 0 to 88 is calculated with increasing scores indicating greater burden experienced.
Measured: The ZBI will be administered at baseline (i.e., prior to starting the study) and immediately after the end of the intervention period (i.e., after a 2-week period).
Change from baseline in the Zarit Caregiver Burden Interview (ZBI) total scores at a 3-week follow up period
Caregiver burden will be assessed using the ZBI. The ZBI is a 22-item self-report questionnaire designed to measure the extent of the burden experienced by the caregivers in various dimensions (e.g., health, psychological well-being, finances, social) of their lives as a result of caregiving. Each item is rated on a Likert scale ranging from 0 (Never) to 4 (Almost always) and indicates how often the caregiver has experienced the described situation. A total score ranging from 0 to 88 is calculated with increasing scores indicating greater burden experienced.
Measured: The ZBI will be administered at baseline (i.e., prior to starting the study) and at a 3-week follow-up period.
Change from after the 2-week period in the Zarit Caregiver Burden Interview (ZBI) total scores at a 3-week follow up period
Caregiver burden will be assessed using the ZBI. The ZBI is a 22-item self-report questionnaire designed to measure the extent of the burden experienced by the caregivers in various dimensions (e.g., health, psychological well-being, finances, social) of their lives as a result of caregiving. Each item is rated on a Likert scale ranging from 0 (Never) to 4 (Almost always) and indicates how often the caregiver has experienced the described situation. A total score ranging from 0 to 88 is calculated with increasing scores indicating greater burden experienced.
Measured: The ZBI will be administered after a 2-week period and at a 3-week follow-up period.
Change from baseline in the Perceived Stress Scale-10 (PSS-10) total scores at 2 weeks
Perceived stress over the course of the intervention will be assessed using the PSS-10. The PSS-10 is a 10-item self-report questionnaire designed to measure general feelings of stress and overload in the past four weeks. Each item is rated on a 5-point Likert scale ranging from 0 (Never) to 4 (Very often). A total score ranging from 0 to 40 is calculated with increasing scores indicating greater stress.
Measured: The PSS-10 will be administered at baseline (i.e., prior to starting the study) and immediately after the end of the intervention period (i.e., after a 2-week period).
Change from baseline in the Perceived Stress Scale-10 (PSS-10) total scores at a 3-week follow up period
Perceived stress over the course of the intervention will be assessed using the PSS-10. The PSS-10 is a 10-item self-report questionnaire designed to measure general feelings of stress and overload in the past four weeks. Each item is rated on a 5-point Likert scale ranging from 0 (Never) to 4 (Very often). A total score ranging from 0 to 40 is calculated with increasing scores indicating greater stress.
Measured: The PSS-10 will be administered at baseline (i.e., prior to starting the study) and at a 3-week follow-up period.
Change from after a 2-week period on the Perceived Stress Scale-10 (PSS-10) total scores at a 3-week follow up period
Perceived stress over the course of the intervention will be assessed using the PSS-10. The PSS-10 is a 10-item self-report questionnaire designed to measure general feelings of stress and overload in the past four weeks. Each item is rated on a 5-point Likert scale ranging from 0 (Never) to 4 (Very often). A total score ranging from 0 to 40 is calculated with increasing scores indicating greater stress.
Measured: The PSS-10 will be administered after a 2-week period and at a 3-week follow-up period.
Change from baseline in the Short-Form Health Survey-12 (SF-12) scores at 2 weeks
Overall well-being will be assessed using the SF-12. The SF-12 was derived from the original 30-item scale and is a self-report questionnaire that measures two dimensions of overall health: physical and mental. Accordingly, the scale consists of a Physical Component (SF-PC) and a Mental Component (SF-MC). Each item in the SF-12 is scored according to the scale's scoring algorithm and combined for each subscale. Total and subscale (SF-PC and SF-MC) scores range from 0 to 100, with increasing normed scores indicating better health and a score of 50 is average.
Measured: The SF-12 will be administered at baseline (i.e., prior to starting the study) and immediately after the end of the intervention period (i.e., after a 2-week period).
Change from baseline in the Short-Form Health Survey-12 (SF-12) scores at a 3-week follow up period
Overall well-being will be assessed using the SF-12. The SF-12 was derived from the original 30-item scale and is a self-report questionnaire that measures two dimensions of overall health: physical and mental. Accordingly, the scale consists of a Physical Component (SF-PC) and a Mental Component (SF-MC). Each item in the SF-12 is scored according to the scale's scoring algorithm and combined for each subscale. Total and subscale (SF-PC and SF-MC) scores range from 0 to 100, with increasing normed scores indicating better health and a score of 50 is average.
Measured: The SF-12 will be administered at baseline (i.e., prior to starting the study) and at a 3-week follow-up period.
Change from after a 2-week period in the Short-Form Health Survey-12 (SF-12) scores at a 3-week follow up period
Overall well-being will be assessed using the SF-12. The SF-12 was derived from the original 30-item scale and is a self-report questionnaire that measures two dimensions of overall health: physical and mental. Accordingly, the scale consists of a Physical Component (SF-PC) and a Mental Component (SF-MC). Each item in the SF-12 is scored according to the scale's scoring algorithm and combined for each subscale. Total and subscale (SF-PC and SF-MC) scores range from 0 to 100, with increasing normed scores indicating better health and a score of 50 is average.
Measured: The SF-12 will be administered immediately after the end of the intervention period (i.e., after a 2-week period) and at a 3-week follow-up period.
Change from baseline in the Dementia Knowledge Assessment Tool Version 2 (DKAT2) total scores at 2 weeks
Knowledge about dementia will be assessed using the DKAT2. DKAT2 is a 21-item self-report questionnaire designed to assess overall knowledge about dementia and dementia care among caregivers and health care staff. The DKAT2 expands from the previous DKAT version (i.e., DKAT1) by including items that are also be pertinent to family members and informal caregivers of people with dementia. Thirteen items in the scale are correct and eight items are incorrect. As such, reversal ratings are required and a score is calculated by summing the total number of correct responses ranging from 0 to 21, with higher scores indicating greater overall knowledge about dementia.
Measured: The DKAT2 will be administered at baseline (i.e., prior to starting the study) and immediately after the end of the intervention period (i.e., after a 2-week period).
Change from baseline in the Dementia Knowledge Assessment Tool Version 2 (DKAT2) total scores at a 3-week follow up period
Knowledge about dementia will be assessed using the DKAT2. DKAT2 is a 21-item self-report questionnaire designed to assess overall knowledge about dementia and dementia care among caregivers and health care staff. The DKAT2 expands from the previous DKAT version (i.e., DKAT1) by including items that are also be pertinent to family members and informal caregivers of people with dementia. Thirteen items in the scale are correct and eight items are incorrect. As such, reversal ratings are required and a score is calculated by summing the total number of correct responses ranging from 0 to 21, with higher scores indicating greater overall knowledge about dementia.
Measured: The DKAT2 will be administered at baseline (i.e., prior to starting the study) and at a 3-week follow-up period.
Change from after a 2-week period in the Dementia Knowledge Assessment Tool Version 2 (DKAT2) total scores at a 3-week follow up period
Knowledge about dementia will be assessed using the DKAT2. DKAT2 is a 21-item self-report questionnaire designed to assess overall knowledge about dementia and dementia care among caregivers and health care staff. The DKAT2 expands from the previous DKAT version (i.e., DKAT1) by including items that are also be pertinent to family members and informal caregivers of people with dementia. Thirteen items in the scale are correct and eight items are incorrect. As such, reversal ratings are required and a score is calculated by summing the total number of correct responses ranging from 0 to 21, with higher scores indicating greater overall knowledge about dementia.
Measured: The DKAT2 will be administered immediately after the end of the intervention period (i.e., after a 2-week period) and at a 3-week follow-up period.

Secondary outcomes (2)

Total System Usability Scale (SUS) score after the 2 week period
Overall app usability will be assessed using the SUS. SUS is a 10-item self-report questionnaire designed to efficiently assess the usability of a technology or product. Each item is rated on a Likert scale ranging from 1 (Strongly disagree) to 5 (Strongly agree). An adjustment rating is needed to account for alternating positive and negative tone items in the instrument. Accordingly, 1 point is subtracted from the raw score of the odd-numbered items, while the raw score of even-numbered items is subtracted from 5. Next, the adjusted scores are added and multiplied by 2.5 to get the standard SUS score. A total score ranging from 5 to 100 is calculated with increasing scores indicating greater agreement and technology usability.
Measured: The SUS will be administered after the end of the intervention period (i.e., after a 2 week period) for app-using participants.
Total Mobile App Rating Scale Subjective App Quality score after the 2 week period
The subjective quality section of the MARS will be used to assess the user's overall app satisfaction. MARS is a 23-item questionnaire designed to assess the quality of mHealth applications. Each item is rated on a Likert scale ranging from 1 (inadequate) to 5 (excellent). The questionnaire includes a 4-item app quality section. A total score is obtained by summing the scores for each item and ranges from 1 to 20, with higher scores indicating greater user quality rating and satisfaction. The four items in the scale assess user's likeliness to recommend/pay for app, extent to which the app stimulates repeated use, and overall app satisfaction.
Measured: The MARS Subjective App Quality Rating will be administered after the end of the intervention period (i.e., after a 2-week period) for app-using participants.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

31 Jan 20225 Jul 2022

First posted1 Feb 2022
Study start31 Jan 2022
Primary completion27 May 2022
Study completion5 Jul 2022

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (11)Papers the sponsor has linked to this study.
Other trials for Caregiver BurdenStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Other
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 175 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT05217004
Sponsor's protocol ID: 2021-177
Status last verified: Feb 2022
First submitted: 19 Jan 2022
Last updated: 21 Apr 2023
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: Yes: All and non-identified numeric data will be made available to other researchers, following the publication of the results, upon reasonable request for a period of at least 7 years. Textual data from the interviews will not be shared to protect participant anonymity.

Publications

Toye C, Lester L, Popescu A, McInerney F, Andrews S, Robinson AL. Dementia Knowledge Assessment Tool Version Two: development of a tool to inform preparation for care planning and delivery in families and care staff. Dementia (London). 2014 Mar 1;13(2):248-56. doi: 10.1177/1471301212471960. Epub 2013 Jan 16.
PubMed 24339059
Ware J Jr, Kosinski M, Keller SD. A 12-Item Short-Form Health Survey: construction of scales and preliminary tests of reliability and validity. Med Care. 1996 Mar;34(3):220-33. doi: 10.1097/00005650-199603000-00003.
PubMed 8628042
Cohen S, Kamarck T, Mermelstein R. A global measure of perceived stress. J Health Soc Behav. 1983 Dec;24(4):385-96. No abstract available.
PubMed 6668417
Stoyanov SR, Hides L, Kavanagh DJ, Zelenko O, Tjondronegoro D, Mani M. Mobile app rating scale: a new tool for assessing the quality of health mobile apps. JMIR Mhealth Uhealth. 2015 Mar 11;3(1):e27. doi: 10.2196/mhealth.3422.
PubMed 25760773
Riffin C, Van Ness PH, Wolff JL, Fried T. Family and Other Unpaid Caregivers and Older Adults with and without Dementia and Disability. J Am Geriatr Soc. 2017 Aug;65(8):1821-1828. doi: 10.1111/jgs.14910. Epub 2017 Apr 20.
PubMed 28426910
Brown EL, Ruggiano N, Li J, Clarke PJ, Kay ES, Hristidis V. Smartphone-Based Health Technologies for Dementia Care: Opportunities, Challenges, and Current Practices. J Appl Gerontol. 2019 Jan;38(1):73-91. doi: 10.1177/0733464817723088. Epub 2017 Aug 4.
PubMed 28774215
Wozney L, Freitas de Souza LM, Kervin E, Queluz F, McGrath PJ, Keefe J. Commercially Available Mobile Apps for Caregivers of People With Alzheimer Disease or Other Related Dementias: Systematic Search. JMIR Aging. 2018 Dec 7;1(2):e12274. doi: 10.2196/12274.
PubMed 31518255
Brooke, J. (1996). SUS-A quick and dirty usability scale. Usability evaluation in industry, 189(194), 4-7.
Zarit, S., Orr, N. K., & Zarit, J. M. (1985). The hidden victims of Alzheimer's disease: Families under stress. NYU press.
Seng BK, Luo N, Ng WY, Lim J, Chionh HL, Goh J, Yap P. Validity and reliability of the Zarit Burden Interview in assessing caregiving burden. Ann Acad Med Singap. 2010 Oct;39(10):758-63.
PubMed 21063635
Bangor, A., Kortum, P. T., & Miller, J. T. (2008). An empirical evaluation of the system usability scale. Intl. Journal of Human-Computer Interaction, 24(6), 574-594.

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 21 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Systematic Evaluation of Mobile Applications for Informal Caregivers of People Living With Dementia
ClinicalTrials.gov ID: NCT05217004
Acronym / sponsor ID: 2021-177
Conditions: Caregiver Burden, Stress, Dementia
Keywords: Apps, mhealth
Study type: Interventional
Recruitment status: Completed
Enrolment: 175 participants (actual)
Lead sponsor: University of ReginaUniversity, hospital or other
Study start: 31 Jan 2022 (actual)
Primary completion: 27 May 2022 (actual)
Study completion: 5 Jul 2022 (actual)
First posted: 1 Feb 2022 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

The purpose of this study is to evaluate the effectiveness of two currently available apps for unpaid caregivers of people living with dementia.

Detailed description

Study design

Primary purpose: Other
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 3

Arm	Type	Receives
Dementia Talk	Experimental	Other: Dementia Talk mobile applicationParticipants in this group will be asked to use the mobile app Dementia Talk over a 2-week period.
CLEAR Dementia Care	Experimental	Other: CLEAR Dementia Care mobile applicationParticipants in this group will be asked to use the mobile app CLEAR Dementia Care over a 2-week period.
Waitlist Control Group	No intervention	–Participants in this group will not use any of the apps.

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Accepted
Age groups: Adult, Older adult

Key inclusion criteria (4 listed)

providing informal care for a person living with dementia (e.g., informal caregivers who are non-professionals; this may include immediate family members such as spouses, children, and other relatives, friends)
living with or providing primary care for the person living with dementia (i.e., the care recipient is not in a long-term care facility)
providing unpaid care
own a smartphone (i.e., an iPhone or Android and/or can access either IOS or Android platforms)

Key exclusion criteria (1 listed)

using an app for caregiver stress/burden

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Dementia Talk mobile applicationThe app includes features for caregivers such as medication management, behavior symptom management and monitoring, stress management tips and strategies, and task management with other care providers.	Other	Dementia Talk
CLEAR Dementia Care mobile applicationThe app provides information about dementia (e.g., types and symptoms of dementia) and allows caregivers to record, monitor, and chart behaviors in the care recipient.	Other	CLEAR Dementia Care

Primary outcome

Change from baseline in the Zarit Caregiver Burden Interview (ZBI) total scores at 2 weeks
Time frame: The ZBI will be administered at baseline (i.e., prior to starting the study) and immediately after the end of the intervention period (i.e., after a 2-week period).
Caregiver burden will be assessed using the ZBI. The ZBI is a 22-item self-report questionnaire designed to measure the extent of the burden experienced by the caregivers in various dimensions (e.g., health, psychological well-being, finances, social) of their lives as a result of caregiving. Each item is rated on a Likert scale ranging from 0 (Never) to 4 (Almost always) and indicates how often the caregiver has experienced the described situation. A total score ranging from 0 to 88 is calculated with increasing scores indicating greater burden experienced.
Change from baseline in the Zarit Caregiver Burden Interview (ZBI) total scores at a 3-week follow up period
Time frame: The ZBI will be administered at baseline (i.e., prior to starting the study) and at a 3-week follow-up period.
Caregiver burden will be assessed using the ZBI. The ZBI is a 22-item self-report questionnaire designed to measure the extent of the burden experienced by the caregivers in various dimensions (e.g., health, psychological well-being, finances, social) of their lives as a result of caregiving. Each item is rated on a Likert scale ranging from 0 (Never) to 4 (Almost always) and indicates how often the caregiver has experienced the described situation. A total score ranging from 0 to 88 is calculated with increasing scores indicating greater burden experienced.
Change from after the 2-week period in the Zarit Caregiver Burden Interview (ZBI) total scores at a 3-week follow up period
Time frame: The ZBI will be administered after a 2-week period and at a 3-week follow-up period.
Caregiver burden will be assessed using the ZBI. The ZBI is a 22-item self-report questionnaire designed to measure the extent of the burden experienced by the caregivers in various dimensions (e.g., health, psychological well-being, finances, social) of their lives as a result of caregiving. Each item is rated on a Likert scale ranging from 0 (Never) to 4 (Almost always) and indicates how often the caregiver has experienced the described situation. A total score ranging from 0 to 88 is calculated with increasing scores indicating greater burden experienced.
Change from baseline in the Perceived Stress Scale-10 (PSS-10) total scores at 2 weeks
Time frame: The PSS-10 will be administered at baseline (i.e., prior to starting the study) and immediately after the end of the intervention period (i.e., after a 2-week period).
Perceived stress over the course of the intervention will be assessed using the PSS-10. The PSS-10 is a 10-item self-report questionnaire designed to measure general feelings of stress and overload in the past four weeks. Each item is rated on a 5-point Likert scale ranging from 0 (Never) to 4 (Very often). A total score ranging from 0 to 40 is calculated with increasing scores indicating greater stress.
Change from baseline in the Perceived Stress Scale-10 (PSS-10) total scores at a 3-week follow up period
Time frame: The PSS-10 will be administered at baseline (i.e., prior to starting the study) and at a 3-week follow-up period.
Perceived stress over the course of the intervention will be assessed using the PSS-10. The PSS-10 is a 10-item self-report questionnaire designed to measure general feelings of stress and overload in the past four weeks. Each item is rated on a 5-point Likert scale ranging from 0 (Never) to 4 (Very often). A total score ranging from 0 to 40 is calculated with increasing scores indicating greater stress.
Change from after a 2-week period on the Perceived Stress Scale-10 (PSS-10) total scores at a 3-week follow up period
Time frame: The PSS-10 will be administered after a 2-week period and at a 3-week follow-up period.
Perceived stress over the course of the intervention will be assessed using the PSS-10. The PSS-10 is a 10-item self-report questionnaire designed to measure general feelings of stress and overload in the past four weeks. Each item is rated on a 5-point Likert scale ranging from 0 (Never) to 4 (Very often). A total score ranging from 0 to 40 is calculated with increasing scores indicating greater stress.
Change from baseline in the Short-Form Health Survey-12 (SF-12) scores at 2 weeks
Time frame: The SF-12 will be administered at baseline (i.e., prior to starting the study) and immediately after the end of the intervention period (i.e., after a 2-week period).
Overall well-being will be assessed using the SF-12. The SF-12 was derived from the original 30-item scale and is a self-report questionnaire that measures two dimensions of overall health: physical and mental. Accordingly, the scale consists of a Physical Component (SF-PC) and a Mental Component (SF-MC). Each item in the SF-12 is scored according to the scale's scoring algorithm and combined for each subscale. Total and subscale (SF-PC and SF-MC) scores range from 0 to 100, with increasing normed scores indicating better health and a score of 50 is average.
Change from baseline in the Short-Form Health Survey-12 (SF-12) scores at a 3-week follow up period
Time frame: The SF-12 will be administered at baseline (i.e., prior to starting the study) and at a 3-week follow-up period.
Overall well-being will be assessed using the SF-12. The SF-12 was derived from the original 30-item scale and is a self-report questionnaire that measures two dimensions of overall health: physical and mental. Accordingly, the scale consists of a Physical Component (SF-PC) and a Mental Component (SF-MC). Each item in the SF-12 is scored according to the scale's scoring algorithm and combined for each subscale. Total and subscale (SF-PC and SF-MC) scores range from 0 to 100, with increasing normed scores indicating better health and a score of 50 is average.
Change from after a 2-week period in the Short-Form Health Survey-12 (SF-12) scores at a 3-week follow up period
Time frame: The SF-12 will be administered immediately after the end of the intervention period (i.e., after a 2-week period) and at a 3-week follow-up period.
Overall well-being will be assessed using the SF-12. The SF-12 was derived from the original 30-item scale and is a self-report questionnaire that measures two dimensions of overall health: physical and mental. Accordingly, the scale consists of a Physical Component (SF-PC) and a Mental Component (SF-MC). Each item in the SF-12 is scored according to the scale's scoring algorithm and combined for each subscale. Total and subscale (SF-PC and SF-MC) scores range from 0 to 100, with increasing normed scores indicating better health and a score of 50 is average.
Change from baseline in the Dementia Knowledge Assessment Tool Version 2 (DKAT2) total scores at 2 weeks
Time frame: The DKAT2 will be administered at baseline (i.e., prior to starting the study) and immediately after the end of the intervention period (i.e., after a 2-week period).
Knowledge about dementia will be assessed using the DKAT2. DKAT2 is a 21-item self-report questionnaire designed to assess overall knowledge about dementia and dementia care among caregivers and health care staff. The DKAT2 expands from the previous DKAT version (i.e., DKAT1) by including items that are also be pertinent to family members and informal caregivers of people with dementia. Thirteen items in the scale are correct and eight items are incorrect. As such, reversal ratings are required and a score is calculated by summing the total number of correct responses ranging from 0 to 21, with higher scores indicating greater overall knowledge about dementia.
Change from baseline in the Dementia Knowledge Assessment Tool Version 2 (DKAT2) total scores at a 3-week follow up period
Time frame: The DKAT2 will be administered at baseline (i.e., prior to starting the study) and at a 3-week follow-up period.
Knowledge about dementia will be assessed using the DKAT2. DKAT2 is a 21-item self-report questionnaire designed to assess overall knowledge about dementia and dementia care among caregivers and health care staff. The DKAT2 expands from the previous DKAT version (i.e., DKAT1) by including items that are also be pertinent to family members and informal caregivers of people with dementia. Thirteen items in the scale are correct and eight items are incorrect. As such, reversal ratings are required and a score is calculated by summing the total number of correct responses ranging from 0 to 21, with higher scores indicating greater overall knowledge about dementia.
Change from after a 2-week period in the Dementia Knowledge Assessment Tool Version 2 (DKAT2) total scores at a 3-week follow up period
Time frame: The DKAT2 will be administered immediately after the end of the intervention period (i.e., after a 2-week period) and at a 3-week follow-up period.
Knowledge about dementia will be assessed using the DKAT2. DKAT2 is a 21-item self-report questionnaire designed to assess overall knowledge about dementia and dementia care among caregivers and health care staff. The DKAT2 expands from the previous DKAT version (i.e., DKAT1) by including items that are also be pertinent to family members and informal caregivers of people with dementia. Thirteen items in the scale are correct and eight items are incorrect. As such, reversal ratings are required and a score is calculated by summing the total number of correct responses ranging from 0 to 21, with higher scores indicating greater overall knowledge about dementia.

2 secondary outcomes

Total System Usability Scale (SUS) score after the 2 week period
Time frame: The SUS will be administered after the end of the intervention period (i.e., after a 2 week period) for app-using participants.
Total Mobile App Rating Scale Subjective App Quality score after the 2 week period
Time frame: The MARS Subjective App Quality Rating will be administered after the end of the intervention period (i.e., after a 2-week period) for app-using participants.

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 21 Apr 2023.
Background: PubMed 24339059Toye C, Lester L, Popescu A, McInerney F, Andrews S, Robinson AL. Dementia Knowledge Assessment Tool Version Two: development of a tool to inform preparation for care planning and delivery in families and care staff. Dementia (London). 2014 Mar 1;13(2):248-56. doi: 10.1177/1471301212471960. Epub 2013 Jan 16.
Background: PubMed 8628042Ware J Jr, Kosinski M, Keller SD. A 12-Item Short-Form Health Survey: construction of scales and preliminary tests of reliability and validity. Med Care. 1996 Mar;34(3):220-33. doi: 10.1097/00005650-199603000-00003.
Background: PubMed 6668417Cohen S, Kamarck T, Mermelstein R. A global measure of perceived stress. J Health Soc Behav. 1983 Dec;24(4):385-96. No abstract available.
Background: PubMed 25760773Stoyanov SR, Hides L, Kavanagh DJ, Zelenko O, Tjondronegoro D, Mani M. Mobile app rating scale: a new tool for assessing the quality of health mobile apps. JMIR Mhealth Uhealth. 2015 Mar 11;3(1):e27. doi: 10.2196/mhealth.3422.
Background: PubMed 28426910Riffin C, Van Ness PH, Wolff JL, Fried T. Family and Other Unpaid Caregivers and Older Adults with and without Dementia and Disability. J Am Geriatr Soc. 2017 Aug;65(8):1821-1828. doi: 10.1111/jgs.14910. Epub 2017 Apr 20.
Background: PubMed 28774215Brown EL, Ruggiano N, Li J, Clarke PJ, Kay ES, Hristidis V. Smartphone-Based Health Technologies for Dementia Care: Opportunities, Challenges, and Current Practices. J Appl Gerontol. 2019 Jan;38(1):73-91. doi: 10.1177/0733464817723088. Epub 2017 Aug 4.
Background: PubMed 31518255Wozney L, Freitas de Souza LM, Kervin E, Queluz F, McGrath PJ, Keefe J. Commercially Available Mobile Apps for Caregivers of People With Alzheimer Disease or Other Related Dementias: Systematic Search. JMIR Aging. 2018 Dec 7;1(2):e12274. doi: 10.2196/12274.
BackgroundBrooke, J. (1996). SUS-A quick and dirty usability scale. Usability evaluation in industry, 189(194), 4-7.
BackgroundZarit, S., Orr, N. K., & Zarit, J. M. (1985). The hidden victims of Alzheimer's disease: Families under stress. NYU press.
Background: PubMed 21063635Seng BK, Luo N, Ng WY, Lim J, Chionh HL, Goh J, Yap P. Validity and reliability of the Zarit Burden Interview in assessing caregiving burden. Ann Acad Med Singap. 2010 Oct;39(10):758-63.
BackgroundBangor, A., Kortum, P. T., & Miller, J. T. (2008). An empirical evaluation of the system usability scale. Intl. Journal of Human-Computer Interaction, 24(6), 574-594.
Individual participant dataSharing planned: Yes. All and non-identified numeric data will be made available to other researchers, following the publication of the results, upon reasonable request for a period of at least 7 years. Textual data from the interviews will not be shared to protect participant anonymity.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Louise IR Castillo, BSc (Hons) principal investigator

University of Regina

Thomas Hadjistavropoulos, PhD principal investigator

University of Regina

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Dementia Talk mobile application and CLEAR Dementia Care mobile application in people with Caregiver Burden and Stress, run by University of Regina at 1 site in Canada.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 21 Apr 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change from baseline in the Zarit Caregiver Burden Interview (ZBI) total scores at 2 weeks (time frame: The ZBI will be administered at baseline (i.e., prior to starting the study) and immediately after the end of the intervention period (i.e., after a 2-week period).). The study lists 12 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05217004, which also lists 11 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Apr 2023.